Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.

Official title

Real-world Observational Study to Evaluate the Effectiveness of Secukinumab in Biologic-naive Ankylosing Spondylitis Patients in Korea

Overview

This is an observational study to evaluate the effectiveness and safety of secukinumab in participants with AS who have never used TNFi, JAKi, or IL-17i drugs before.

Detailed description

This study is an observational study to evaluate the effectiveness and safety of secukinumab in patients with ankylosing spondylitis who are naive to TNFi/JAKi/IL-17i in Korea. Subjects will be recruited from 10 institutions in Korea. The enrollment period is 8 months from the initiation at the first institution and the follow-up periods are 28 weeks(±4 weeks). Data will be gathered at initial visit, 16 weeks(±4 weeks), and 28 weeks(±4 weeks).

Secukinumab is prescribed within the scope of labeling approved in Korea.

Interventions

• Drug Secukinumab
  This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

Primary outcome measures

• Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time frame: Baseline and 28 weeks]

Secondary outcome measures (4)

• Change from baseline in C-Reactive Protein (CRP) [Time frame: Baseline, 16 and 28 weeks]
• Change from baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP [Time frame: Baseline, 16 and 28 week]
• Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) stratified by specific variables [Time frame: Baseline, 16 and 28 weeks]
• Adverse events and Serious Adverse events [Time frame: From baseline up to 28 weeks]

Eligibility criteria

Inclusion criteria

• Subjects diagnosed with ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria
• Subjects who have symptoms of active disease at screening and baseline, as evidenced by BASDAI score of ≥ 4
• Subjects who have never used TNFi, JAKi, or IL-17i drugs before
• Patients suitable for secukinumab treatment within the scope of labeling by the Ministry of Food and Drug Safety
• Subjects who have a time of less than 5 years since AS diagnosis
• Subjects who are above the age of 18 years and below 40years old
• Subjects who give informed consent form to participate in the study

Exclusion criteria

• Subjects who are in a medical or psychological condition which may prevent them from participating in the study for the study period(28±4 weeks)
• Subjects who have congenital/traumatic spinal deformities
• Subjects currently enrolled in other clinical studies
• Subjects who have any contraindications to secukinumab treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

South Korea · 2 centers

• Novartis Investigative Site — Jinju
• Novartis Investigative Site — Busan

Publications

• Chimenti MS, Fonti GL, Conigliaro P, Sunzini F, Scrivo R, Navarini L, Triggianese P, Peluso G, Scolieri P, Caccavale R, Picchianti Diamanti A, De Martino E, Salemi S, Birra D, Altobelli A, Paroli M, Bruzzese V, Lagana B, Gremese E, Conti F, Afeltra A, Perricone R. One-year effectiveness, retention rate, and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a real-life multic PMID 32401062
• Kiltz U, Sfikakis PP, Gaffney K, Sator PG, von Kiedrowski R, Bounas A, Gullick N, Conrad C, Rigopoulos D, Lespessailles E, Romanelli M, Ghislain PD, Brandt-Jurgens J, Rashkov R, Aassi M, Orsenigo R, Perella C, Pournara E, Gathmann S, Jagiello P, Veit J, Augustin M. Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in PMID 32378070
• Dzubur E, Khalil C, Almario CV, Noah B, Minhas D, Ishimori M, Arnold C, Park Y, Kay J, Weisman MH, Spiegel BMR. Patient Concerns and Perceptions Regarding Biologic Therapies in Ankylosing Spondylitis: Insights From a Large-Scale Survey of Social Media Platforms. Arthritis Care Res (Hoboken). 2019 Feb;71(2):323-330. doi: 10.1002/acr.23600. PMID 29781587
• Micheroli R, Tellenbach C, Scherer A, Burki K, Niederman K, Nissen MJ, Zufferey P, Exer P, Moller B, Kyburz D, Ciurea A. Effectiveness of secukinumab versus an alternative TNF inhibitor in patients with axial spondyloarthritis previously exposed to TNF inhibitors in the Swiss Clinical Quality Management cohort. Ann Rheum Dis. 2020 Sep;79(9):1203-1209. doi: 10.1136/annrheumdis-2019-215934. Epub 202 PMID 32581090
• Wang R, Ward MM. Epidemiology of axial spondyloarthritis: an update. Curr Opin Rheumatol. 2018 Mar;30(2):137-143. doi: 10.1097/BOR.0000000000000475. PMID 29227352
• Mauro D, Forte G, Poddubnyy D, Ciccia F. The Role of Early Treatment in the Management of Axial Spondyloarthritis: Challenges and Opportunities. Rheumatol Ther. 2024 Feb;11(1):19-34. doi: 10.1007/s40744-023-00627-0. Epub 2023 Dec 18. PMID 38108992

Identifiers

NCT: NCT06905288 · CAIN457HKR01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗